Magnesium Sulfate for Bronchiolitis

Overseen By Janice Sullivan, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Louisville

Disqualifiers: Chronic lung disease, congenital heart disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 20 minutes

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to more rigorously evaluate the response to a single bolus of magnesium sulfate in a population of patients with moderate to severe bronchiolitis. The primary outcome will be to evaluate the effect of this therapy on clinical respiratory status. Secondary outcomes of interest will include the incidence of adverse effects and safety profile of magnesium bolus use in this population.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the drug Magnesium Sulfate for treating bronchiolitis?

Research shows that both nebulized and intravenous magnesium sulfate can help improve breathing in children with bronchiolitis by reducing respiratory distress and the need for additional oxygen support. It has also been effective in quickly improving airflow in severe asthma cases, suggesting its potential benefit in similar respiratory conditions like bronchiolitis. ^{1 2 3 4 5}

Is magnesium sulfate safe for use in humans?

Magnesium sulfate has been studied for safety in various conditions, including asthma and bronchiolitis, and is generally considered safe when used appropriately. It has been used both intravenously and as an inhaled treatment, with studies indicating it can be safely administered outside of critical care settings. ^{1 2 3 6 7}

How does the drug Magnesium Sulfate differ from other treatments for bronchiolitis?

Magnesium Sulfate is unique because it is often used for its muscle relaxant properties, which can help open up the airways in the lungs, potentially providing relief for bronchiolitis. Unlike other treatments that may focus on reducing inflammation or infection, Magnesium Sulfate works by relaxing the muscles around the airways, which can help improve breathing. ^{8 9 10 11 12}

Research Team

John W Berkenbosch, MD

Principal Investigator

University of Louisville

Eligibility Criteria

This trial is for infants under 12 months old with moderate to severe bronchiolitis, admitted to the pediatric intensive care unit within the last 24 hours. Parents must consent for their child's participation. Infants with cyanotic heart disease, chronic lung disease, or unrepaired congenital heart disease cannot participate.

Inclusion Criteria

I was admitted to the Pediatric Intensive Care Unit less than 24 hours ago.

Parent/LAR consents for infant to participate

You have moderate to severe bronchiolitis based on a specific scoring system.

Exclusion Criteria

I have a heart condition from birth that hasn't been fixed.

I have a long-term lung condition.

I have a heart condition that causes bluish skin from poor circulation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a bolus of 50mg/kg Magnesium Sulfate or placebo over twenty minutes

20 minutes

1 visit (in-person)

Monitoring

Participants are monitored for vital signs and MPIS for six hours post-treatment

6 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Magnesium Sulfate

Trial Overview The study tests how a single dose of magnesium sulfate affects infants with bronchiolitis in terms of breathing and overall respiratory health. It also looks at any side effects and safety concerns associated with this treatment.

Participant Groups

Group I: Magnesium Sulfate Experimental Treatment 1 Intervention

The patient will receive a bolus of 50mg/kg MgSO4 over twenty minutes.

Group II: Placebo Placebo Group 1 Intervention

The patient will receive a bolus of Normal Saline over twenty minutes.

Magnesium Sulfate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment
• Constipation treatment

Approved in European Union as Magnesium sulphate for:

• Pre-eclampsia and eclampsia treatment
• Hypomagnesemia treatment

Approved in Canada as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Findings from Research

In a study of 54 children with moderate to severe asthma exacerbations, the administration of high-dose magnesium sulfate did not significantly improve asthma symptoms compared to a placebo, as measured by Pulmonary Index scores.

There was no notable difference in hospitalization rates or time to meet discharge criteria between the magnesium and placebo groups, indicating that magnesium sulfate may not be an effective routine treatment for acute asthma in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of magnesium in the emergency department treatment of children with asthma. Scarfone, RJ., Loiselle, JM., Joffe, MD., et al.[2006]

A review of 16 studies indicates that intravenous bolus magnesium sulphate is safe for treating children with acute severe asthma in non-critical care settings.

Safety measures, such as line of sight nursing and cardiorespiratory monitoring, are essential when administering magnesium sulphate to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is intravenous magnesium sulphate safe to be administered outside the critical care setting? de Havilland, A., Hariharan, G., Puvvadi, R.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

Nebulized Magnesium Sulfate in Acute Bronchiolitis: A Randomized Controlled Trial. [2018]

2. India pubmed.ncbi.nlm.nih.gov

Nebulized Magnesium Sulphate in Bronchiolitis: A Randomized Controlled Trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of status asthmaticus with intravenous magnesium sulfate. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Intravenous Magnesium Sulfate for Acute Bronchiolitis: Evaluation of the Effect on Clinical Course and Outcomes. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of magnesium in the emergency department treatment of children with asthma. [2006]

6. Australia pubmed.ncbi.nlm.nih.gov

Is intravenous magnesium sulphate safe to be administered outside the critical care setting? [2022]

7. England pubmed.ncbi.nlm.nih.gov

Inhaled magnesium sulphate in the treatment of bronchial hyperresponsiveness. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of a highly-concentrated sulphate-rich synthetic wastewater using calcium hydroxide in a fluidised bed crystallizer. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Recovering chemical sludge from the zero liquid discharge system of flue gas desulfurization wastewater as flame retardants by a stepwise precipitation process. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Sulfate removal from wastewater using ettringite precipitation: Magnesium ion inhibition and process optimization. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

Antiviral activities of heated dolomite powder. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Preparation and Heat of Formation of a Magnesium Oxysulfate. [2023]